NCT02555722

Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized, lens blocked (subjects remain in the same lens brand throughout the study) concurrent control study enrolling up to 90 subjects with a study duration of approximately three months. Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control).

Detailed description

Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control). This should result in a study population of approximately 60 test subjects and 30 control subjects.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	fanfilcon A (test)	silicone hydrogel lens
DEVICE	enfilcon A (control)	silicone hydrogel lens

Timeline

• Start date: 2015-09-21
• Primary completion: 2016-01-27
• Completion: 2016-05-01
• First posted: 2015-09-21
• Last updated: 2019-09-25
• Results posted: 2017-03-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study